IRB Transition

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Questions

1. Will our studies that transfer into the new system change determination status if they fall under the new exempt categories (i.e., Brief Benign Behavioral Interventions)?
   • The new categories will be applied to new reviews submitted after 01/21/19 with all the new forms. Studies that are already sorted into Expedited review categories would stay in expedited, unless you do a whole resubmission with all the new forms.
2. What exactly does exempt status entail for studies in this category, in terms of record-keeping and consent forms?
3. We have had issues with personnel leaving the lab and being removed from our protocols via amendment, only for them to continue appearing on our reviewers’ end, eventually culminating in our submissions being “on hold until human subjects training is renewed”. Is Huron expected to handle the interface between researchers’ and reviewers’ view of submissions any better than the old system?
   • there is no reason to expect this will be a problem. IRB thinks this was a quirk of the old system being built on top of an even older legacy system.

IRB training

Project Wahoo

• Training Powerpoint
  1. Toolkit changes
  2. Common Rule changes
  3. Software

Software transition

What to expect

• some things will transfer, some will not

What information will not transfer

• Exempt Determinations: HRP-255
  • I don’t think this applies to any of our studies
• Not Human Subjects Research (NHSR) Determinations: HRP-250
  • Publicly available, deidentified, secondary data
• Rely-Upon Determinations
  • Applies to projects where an external IRB is being deferred to
  • Consumer Judgment study might apply?

Investigator Manual Updates: HRP-103

• addditional guidance on required training and who is eligible to serve as PI
• major changes to software instructions
• additional guidance on what group of forms/templates to use
• additional guidance on modification and continuing review requests
  • continuing review allows modifications so you don’t need to submit both if there are changes to be made at CR time
• additional single IRB (sIRB) informations for multi-site studies

Informed Consent Form Changes: HRP-502 & HRP-502b

• major change-key information vs detailed information
  • link > ?
• additional language for studies involving the collection of identifiable information and biospecimens
• what hasn’t changed? a lot of template language for you to select from and delete if not applicable

protocol changes (expedited and board studies) HRP-403

• major reorganization
  • multi-site information moved to the end
• added revision history (!!!!)
• added study summary
• what hasn’t changed?
  • a lot of template language for you to select from and delete if not applicable

Toolkit Numbering Changes / New Forms

Was:	Now:
HRP-500 Research Activity Form	HRP-250 Request For NHSR Determination
HRP-509 Summary Explanation Exempt Research	HRP-254 Summary Explanation Exempt Research
HRP-509 Request for Exempt Determination	HRP-255 Request for Exempt Determination
Individual Investigator Agreement	HRP-252 Individual Investigator Agreement

Forms Page has updated

Routing Changes

• currently, new submissions require PI, faculty advisor, and departmental signoff prior to submission to IRB
• Updates:
  • HRP-251 Faculty Advisor Review
    • faculty advisors complete the review form
    • student PI to upload the form with the study submission
    • submissions without the form will be returned without additional review
  • Faculty advisor and departmental sign-off added as an Ancillary Reviewer
    • Ancillary review may take place concurrently with IRB review

Instead of routing a submission through Nichole before it goes to the IRB, we would either have her fill out HRP-251 and attach with the submission, or have her added an Ancillary Reviewer, along with Department Chair or whoever else is signing off, for their review in parallel with IRB review.

Undergraduate Researchers: Faculty advisor should serve as the PI and use HRP-251 to review the process with the undergrad.

(!!!) Everyone is already in the system, as long as they have a UCF NID (!!!)

External team members

• Currently listed on iRIS application in Sub-section 4.4
  • includes both engaged collaborators and other contacts
• Now its own form; only use if applicable
  • HRP-253 External Members

Common Rule Change

• will go into effect: 01/21/19 after the December toolkit & Software changes
• mostly IRB SOPs and Worksheets
• major changes for researchers
  • changes to exempt categories:
    • “Brief Benign Behavioral Interventions” (!!!)
      • not a clear definition for “brief”, but sounds like all of our studies would apply
      • anything half-a-day or less, probably, including pre- and post-intervention measurements, etc.
    • “Limited irb review”
    • New instructions for restrospective data review “Secondary Research”
    • relevant protocol documents supposedly ready as of now, with template language for these categories
• Will require new further toolkit changes

additional IRB-offered trainings

• 101 workshops
• IRB @ your doorstep
  • 101 workshop & Individual Consultation

Software

1. Navigation
2. Creating a study
3. Respond to Clarifications
4. Mod CR
5. RNIs

Creating a new study

Smartform very much like UF IRB

1. Title
2. Short Title
3. Description
4. Principal Investigator
5. Fincancial Interest declaration
6. external irb
7. what kind of study
   • multi-site, single site, collaborative, etc.
8. Attach protocol
   • version numbering
9. Funding Sources
   • not required if N/A, but you can list funding organization, grants office, files, sponsor IDs, etc.
10. Study Team
    1. Identify each additional person
       • Co-PIs, Sub-Is, Coordinator, Research Assistant
       • involved in consent, financial interest, private data access
    2. External team members
       • Individual Investigator Agreement upload
11. Study Scope
    • each of these add a page to the smartform:
      1. other research locations
      2. approved drugs, biologics,
      3. devices
12. Local Site Documents
    1. consent forms, recruitment materials, other attachments
13. Additional Information
    1. classify the PI, list Faculty Research advisor, etc.
    2. does the research take place online, or
    3. include any vulnerable populations, or
    4. department of navy affiliation
       1. citi certifications
          • why is this under NAVY and not elsewhere?
          • oh, it is. on the study workspace you can see team members’ training status. this section doesn’t matter for us I think
    5. protected health information
    6. international research
    7. international traffic in arms regulations
14. Final Page
    1. Finish
       • Does not submit the study
15. Study Workspace
    • Like a “Landing Page”. Several things available here.
    • Sidebar:
      1. Next steps
         1. edit study
         2. printer friendly
         3. view revision differences
      2. Activities
         1. (!) Submit
         2. assign primary contacts
            • default is principal investigator but you can change
         3. manage ancillary reviews
            • unsure exactly how psychology department and college of sciences will want to handle it
            • could be irrelevant for us, could be that we need to add chair, dean, or both
            • can be used for faculty advisor as well
              • basically replaces the routing process but in parallel
              • probably the preferred method is to do the faculty advisor review form above
         4. guest list
            • gives individuals “view access”
         5. comments
            • questions, comments for the irb or the other team members, supporting documents, contacts for the comment
         6. copy submission
            • (!) create a new submission with all the same settings so you don’t need to fill out the team the same every time
         7. discard, grants
    • Main Section:
      1. shows a workflow diagram
         1. pre-submission
         2. pre-review
         3. irb review
         4. post-review
         5. review complete
      2. Tabs:
         • History
         • Funding
         • Contacts
         • CITI training
         • Documents
         • Reviews
         • Snapshots

Respond to clarifications

IRB responses land in your inbox. If you need to modify forms like consent form you want to use the UPDATE button, unless you specifically need to add an additional consent form, such as for a second study population. Save changes to smart form and in the Workspace Activities section on the sidebar, Submit Response:

1. Notes, supporting documents
   • supporting documents is only if that is the way you’re tracking the requested modifications, not for attaching updated forms that go in the smartform.

Modification / Continuing Review

This process is a unified smartform. For converted studies from the old system, the very first time we submit a continuing review we will need to classify it as a Modification/Continuing Review in order to bring in certain data from the previous system. Not a lot is actually being automatically migrated, so things like study forms will need to be reuploaded as the new form templates.

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